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Wednesday, June 29, 2022

Genocea Biosciences Inc (OTCMKTS: GNCA) Ex NASDAQ Biotech Heating up and Making Moves on the OTC As Co Winds Down Operations

Genocea Biosciences Inc (OTCMKTS: GNCA) is coming up off $0.012 lows reached shortly after GNCA began trading on the OTC pink sheets. The stock was delisted from the NASDAQ after the Company announced they were winding down their operations. GNCA could however, trade on the pink sheets for quite a while. According to the 10Q filed on May 5, GNCA has a strong balance sheet with $20 million in the treasury, over 4 million in pre-paid expenses and $38 million in assets vs. $18 million in liabilities. GNCA has just 58,783,503 shares outstanding and trades for a valuation of less than $1 million USD. 

On May 23 GNCA announced its Board of Directors voted to wind down the Company’s ongoing operations and terminate the Company’s remaining employees except those deemed necessary to complete an orderly wind down. The Company delivered formal notice to The Nasdaq Stock Market, Inc. of its intent to voluntarily delist its Common Stock from the Nasdaq Capital Market in connection with the wind down of its operations. The Company plans to file a Form 25 with the Securities and Exchange Commission on or about June 2, 2022, to effect the voluntary delisting of the Common Stock under Section 12(b) of the Securities Exchange Act of 1934, as amended. Also, on May 23, 2022, the Company received a letter from the Nasdaq Listing Qualifications department of Nasdaq notifying the Company that it was not in compliance with the requirement of Nasdaq Marketplace Rule 5450(a)(1) for continued inclusion on The Nasdaq Capital Market as a result of the closing bid price for the Company’s common stock being below $1.00 for 30 consecutive business days. 

 

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Genocea Biosciences Inc (OTCMKTS: GNCA) is a biopharmaceutical company dedicated to discovering and developing novel cancer immunotherapies using our proprietary ATLASTM platform. The ATLAS platform can profile each patient’s CD4+ and CD8+ T cell immune responses to every potential target or “antigen” identified by next-generation sequencing of that patient’s tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, or InhibigensTM, that drive pro-tumor immune responses. We believe this approach ensures that cancer immunotherapies, such as cellular therapies and vaccines, focus T cell responses on the tumor antigens most vulnerable to T cell targeting. Consequently, we believe that ATLAS may enable more immunogenic and efficacious cancer immunotherapies. Up until May 23, 2022 GNCA was trading on the NASDAQ  

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GEN-011 is an investigational next-generation solid tumor cell therapy candidate comprised of CD4+ and CD8+ neoantigen-targeted peripheral T cells (“NPTs”) which are specific for up to 30 antigens, designed to limit tumor escape. GEN-011 is comprised of T cells extracted from the patient’s peripheral blood and specific for ATLAS-prioritized neoantigens. NPTs have minimal bystander, non-tumor-specific cells, and are designed to be devoid of Inhibigen-specific cells which may be detrimental to clinical response. GEN-011 has the potential to be differentiated from other cell therapies because of the breadth of surface-presented neoantigens it targets and the ease of manufacturing tumor-relevant T cells extracted from readily accessible peripheral blood. TiTAN is an open-label, multi-center Phase 1/2a trial evaluating the safety, tolerability, T cell persistence and proliferation, and clinical efficacy of GEN-011. The TiTAN clinical trial is testing two dosing regimens. Initial data from the TiTAN trial is expected during the American Association for Cancer Research (“AACR”) Annual Meeting 2022 to be held from April 8 – 13, 2022. 

GEN-009 is an investigational neoantigen vaccine delivering adjuvanted synthetic long peptides from ATLAS-identified neoantigens. We reported long-term immunogenicity and clinical response data from our GEN-009 neoantigen vaccine Phase 1 clinical trial in November 2021, and we continue to monitor patients to further evaluate these efficacy signals. 

Harnessing and directing T cells to kill tumor cells is increasingly viewed as having potential to treat many cancers. Cellular therapies or vaccines employing this approach may be most effective when targeting specific differences from normal tissue present in the patient, such as antigens arising from genetic mutations or cancer-causing viruses. However, the discovery of optimal antigens for such immunotherapies has been particularly challenging for two reasons. First, the number of candidate antigens can be very large, with up to thousands of candidates per patient in some cancers. Second, the genetic diversity of human T cell responses means that effective antigens may vary from person to person. An effective antigen selection system must therefore account both for each patient’s tumor and for their T cell repertoire. 

ATLAS selects antigens through an ex vivo assay that unveils CD4+ and CD8+ T cell immune responses each patient has made to nearly any possible tumor-specific antigen, including candidate neoantigens, tumor-associated antigens and tumor-associated viral antigens. In doing so, we believe that ATLAS provides the most comprehensive and accurate system for identifying the right and wrong antigens for cancer immunotherapies. Previously, all candidate antigens were thought either to be targets of effective anti-tumor responses (stimulatory) or irrelevant. However, using ATLAS, we have identified Inhibigens and demonstrated, in preclinical studies, that such antigens can promote rapid tumor growth, reduce or eliminate the protection of an otherwise effective vaccine, and dampen or reverse the effects of checkpoint inhibitors (“CPI”). We therefore believe that both by identifying the optimal antigens and by excluding Inhibigens, ATLAS enables differentiated immune responses and clinical efficacy. 

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Currently trading at a $750,000 market valuation GNCA is high risk gambling that could pay off big for those willing to take the risk.  The stock was delisted from the NASDAQ after the Company announced they were winding down their operations. GNCA could however, trade on the pink sheets for quite a while. According to the 10Q filed on May 5, GNCA has a strong balance sheet with $20 million in the treasury, over 4 million in pre-paid expenses and $38 million in assets vs. $18 million in liabilities. GNCA has just 58,783,503 shares outstanding. In 2014 GNCA was $180 per shares on the NASDAQ and the stock was heavily shorted on the way down. At $0.0175 it’s a risky trade that could pay off bigtime. We will be updating on GNCA when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with GNCA.

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Disclosure: we hold no position in GNCA either long or short and we have not been compensated for this article

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